Alexandria

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Researchers are evaluating whether adding zilovertamab vedotin to a standard treatment regimen can help people with previously untreated diffuse large B-cell lymphoma DLBCL live longer without the cancer growing or spreading. This phase 3 randomized study compares the combination of zilovertamab vedotin with rituximab plus cyclophosphamide, doxorubicin, and prednisone R-CHP against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone R-CHOP. The trial is sponsored by Merck Sharp & Dohme LLC and aims to improve treatment outcomes for people with this type of lymphoma. Participants receive treatment in cycles lasting 21 days, for up to 6 cycles approximately 4 months. One group receives zilovertamab vedotin plus rituximab or a rituximab biosimilar, cyclophosphamide, doxorubicin, and prednisone or prednisolone or methylprednisolone, while the comparison group receives rituximab or biosimilar, cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone or methylprednisolone. Both groups may receive 2 additional cycles of rituximab or biosimilar if they have high-risk DLBCL. All infusions are given intravenously on Day 1 of each cycle, with prednisone or similar drugs taken orally on Days 1-5 of each cycle. Throughout the study, participants are closely monitored for progression-free survival up to about 50 months, as well as other outcomes such as overall survival, response to treatment, adverse events, and quality of life changes. Assessments include clinical evaluations during treatment and follow-up periods, with safety monitoring continuing for up to 9 months. This comprehensive follow-up helps researchers understand the effects and tolerability of the treatments over time.

Researchers are studying the Caris Biorepository, a project designed to collect and store high-quality biological specimens and related clinical data to support research aimed at advancing precision medicine and improving patient care. This observational study focuses on gathering samples and information from various sources, including healthy individuals and cancer patients, to help understand disease treatments and clinical outcomes. The biorepository includes samples from different donor groups, such as those with no disease, treatment-nave patients with new solid tumors, individuals at higher risk for cancer, patients with advanced cancer, and those with a history of cancer but no active disease. The project aims to maintain molecular integrity and clinical relevance of these specimens while providing access to researchers and collaborators for drug development, clinical trials, and healthcare policy enhancements. Participants provide informed consent and contribute biological samples and clinical data that are securely stored and shared for research purposes. The study measures include ensuring specimen quality and relevance over 35 years and facilitating specimen release for testing. Laboratory testing will be conducted throughout the study duration. The project supports long-term research collaboration and aims to impact patient outcomes and treatment practices over time.

The trial investigates the effectiveness of NeoThelium FT combined with standard care compared to standard care alone in treating diabetic foot ulcers. This open-label randomized controlled crossover study is conducted across multiple medical centers and aims to evaluate wound healing outcomes and pain relief in patients with chronic diabetic foot ulcers. The study includes adult participants with diabetes mellitus who have ulcers that meet specific criteria. Participants are randomly assigned to receive either standard care alone or standard care plus NeoThelium FT, a wound covering made from human placental tissue. Those initially receiving standard care who do not achieve complete wound closure by about 84 days may cross over to the NeoThelium FT treatment arm, receiving weekly applications for up to 12 visits. All participants undergo a two-week screening before randomization. During the study, participants have regular assessments including wound measurements and pain evaluations at specific intervals over 12 weeks. Researchers monitor the percentage of ulcers achieving full closure, wound area reduction, time to closure, and pain levels. The trial supports gathering data for insurance reimbursement decisions and tracks participants through follow-up visits according to the study schedule.

Researchers are evaluating the effectiveness of Hyalomatrix, a hyaluronic acid-based wound dressing, combined with standard of care SOC compared to SOC alone in treating venous leg ulcers. This open-label, randomized controlled trial includes adults diagnosed with venous leg ulcers or venous insufficiency with lower extremity wounds, aiming to assess wound healing over a 12-week period and support insurance reimbursement decisions. Participants will be randomly assigned to either receive SOC alone, which includes wound cleansing, sharps debridement, moisture-balancing dressings, and compression therapy, or SOC plus weekly Hyalomatrix applications. Subjects in the SOC group who do not achieve complete wound closure by about 84 days post-randomization and meet eligibility criteria may cross over to receive Hyalomatrix treatment for up to 12 weeks while continuing follow-up visits. During the study, participants will attend treatment visits where wound healing progress, pain levels, and wound area reduction are monitored regularly. Researchers will measure complete wound closure within 1 to 12 weeks as the primary outcome, along with weekly percentage area reduction and pain assessments for up to 14 weeks. The study emphasizes ongoing safety and efficacy monitoring throughout the treatment and follow-up periods.

This research registry collects prospective information on patients managing chronic pain caused by knee osteoarthritis OA or optimizing pain treatment for knee replacement surgery due to knee OA. It aims to gather data on various pain therapies used for OA, including cryo nerve block, radiofrequency ablation RFA, injections like corticosteroids, viscosupplementation, opioids, and other medications such as non-steroidal anti-inflammatory drugs NSAIDs. Participants receive different pain management treatments as part of their care for knee OA, which may include procedures like nerve blocks or injections, or undergo knee arthroplasty if needed. The registry monitors these therapies and treatments over time without assigning specific interventions since it is observational. Throughout the study, participants provide information through questionnaires and medication logs to track pain levels using scales like the Numeric Rating Scale NRS and Brief Pain Inventory-short form BPI-sf, functional status through knee outcome scores, quality of sleep, opioid use, adverse events, patient satisfaction, healthcare utilization, and other health-related quality of life measures. Data collection continues for up to 18 months to observe outcomes and treatment effects over time.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

Researchers are evaluating the use of NeoThelium FT Amnion Skin Graft in managing diabetic foot ulcers. This prospective case series aims to assess the safety and effectiveness of this treatment in patients with diabetes who have foot ulcers. The study is open label and conducted across multiple medical centers, focusing on gathering evidence to support insurance coverage decisions. Participants will receive standard care combined with weekly applications of NeoThelium FT, which is a dehydrated membrane made from donated human placental tissue. The treatment includes wound cleansing, sharp debridement, application of the graft, dressing to maintain moisture balance, and offloading to protect the wound. Patients continue follow-up visits according to the original schedule, with close monitoring throughout the study. During the trial, researchers will track wound healing progress, including the time to complete wound closure within 1 to 12 weeks. They will also measure changes in wound area, hemoglobin A1c levels, and follow-up wound closure two weeks after treatment. Safety and treatment effectiveness are monitored with regular assessments, and participation may last up to 12 weeks or more depending on healing progress.